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Mainstay Medical Australia Pty Ltd

Sponsor (Registration Holder) · 18 devices on the TGA ARTG · 4 device classes · Dec 16, 2016Feb 21, 2023

18
Total Devices
4
Device Classes
2016
Earliest
2023
Latest
Recent device registrations
Latest 10 TGA ARTG device registrations
Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
ARTG 405210
Class IIIFeb 21, 2023
Manufacturer: Oscor Incorporated
Adelante peel away introducer system - model number AP0716GW2-BX5 - Vascular introducer kit
Class IIIFeb 21, 2023
Manufacturer: Oscor Incorporated
ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead
ARTG 327091
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Programmer Wand - Implantable lumbar neuromuscular electrical stimulation system programmer
ARTG 327092
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Magnet - Implantable stimulator control magnet
ARTG 327094
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Application Software - Implantable electrical stimulation device management software
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Magnet - Implantable stimulator control magnet
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Percutaneous Lead - Implantable lumbar neuromuscular electrical stimulation system lead
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Application Software - Implantable electrical stimulation device management software
ARTG 327093
Class IIIDec 04, 2019
Manufacturer: Mainstay Medical Limited
ReActiv8 Implantable Pulse Generator - Implantable lumbar neuromuscular electrical stimulation system pulse generator
ARTG 327089
AIMDDec 04, 2019
Manufacturer: Mainstay Medical Limited
Risk class distribution
Devices by risk class
Class IIa
2
11.1% of total
Class III
12
66.7% of total
Class Is
2
11.1% of total
AIMD
2
11.1% of total
About this profile

Explore comprehensive sponsor profile for Mainstay Medical Australia Pty Ltd through Pure Global AI's free Australia TGA ARTG medical device database. This company has sponsored 18 medical devices registered with TGA ARTG across 4 device classes. Their sponsorship history spans from Dec 16, 2016 to Feb 21, 2023.

In Australia, the sponsor is the legal entity responsible for the medical device's compliance with TGA regulations and ARTG registration. This page provides detailed insights including recent device registrations, risk class distribution (Class III: 12, Class Is: 2, Class IIa: 2, AIMD: 2), and complete regulatory information from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices.

Free Sponsor ProfilePowered by Pure Global AI18 Devices4 Device Classes